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Erratum: Inadvertent Stent Retriever Detachment: A Multicenter Case Series and Review of Device Experience FDA Reports

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DataCite Commons2020-09-01 更新2024-07-25 收录
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https://karger.figshare.com/articles/dataset/Erratum_Inadvertent_Stent_Retriever_Detachment_A_Multicenter_Case_Series_and_Review_of_Device_Experience_FDA_Reports/5241892
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Mechanical thrombectomy using retrievable stents or stent retriever devices has become the mainstay of intra-arterial therapy for acute ischemic stroke. The recent publication of a series of positive trials supporting intra-arterial therapy as standard of care for the treatment of large vessel occlusion will likely further increase stent retriever use. Rarely, premature stent detachment during thrombectomy may be encountered. In our multicenter case series, we found a rate of detachment of less than 1% (n = 7/1,067), and all were first-generation Solitaire FR devices. A review of the US Food and Drug Administration database of device experience yielded 90 individual adverse reports of detachment. There were 82, 1 and 7 detachments of Solitaire FR (first generation), Solitaire FR2 (second generation) and Trevo devices, respectively. We conclude with a brief overview of the technical and procedural considerations which may be helpful in avoiding this rare complication.

采用可回收支架或支架取栓装置的机械取栓术,现已成为急性缺血性脑卒中动脉内治疗的主流手段。近期一系列证实动脉内治疗可作为大血管闭塞治疗标准护理方案的阳性临床试验发表,或将进一步推动支架取栓装置的临床应用。取栓过程中偶可出现支架过早脱载的不良事件。在本项多中心病例系列研究中,我们统计的支架脱载发生率不足1%(7/1067),且所有脱载病例均使用第一代Solitaire FR取栓支架。对美国食品药品监督管理局(US Food and Drug Administration)器械不良事件数据库进行检索后,共获得90例支架脱载的个体不良事件报告。其中第一代Solitaire FR、第二代Solitaire FR2以及Trevo取栓装置的脱载病例数分别为82例、1例和7例。文末我们将简要概述可用于规避该罕见并发症的技术与操作要点。
提供机构:
Karger Publishers
创建时间:
2017-07-25
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